Understanding your FASLODEX treatment

Whether you and your doctor are considering FASLODEX, or you are already receiving FASLODEX, it’s important to understand how your medicine works—and what that means for your advanced breast cancer treatment.

What is FASLODEX?

FASLODEX is a prescription medicine used to treat women with:

  • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
  • HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
  • HR-positive, HER2-negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib in women whose disease has progressed after endocrine therapy

Most breast cancers are hormone receptor-positive. FASLODEX can be used in hormone receptor-positive breast cancer because it is designed to target the estrogen receptor, which is a hormone receptor that is present in this type of breast cancer.

FASLODEX may be an appropriate choice for you whether it is used alone or with either palbociclib or abemaciclib. Talk to your doctor about which option may be best for you.

If you have hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer and have not been given endocrine therapy for advanced breast cancer, and have gone through menopause, FASLODEX may be an option for your first hormonal therapy. Based on the results of a clinical study called FALCON, FASLODEX can be used instead of an aromatase inhibitor called anastrozole.

Now, let’s break down some of those terms. Understanding these terms can help you take on more of an active role in your treatment.

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Hormone receptor-positive

Breast cancer can be either hormone receptor-positive or hormone receptor-negative. Hormone receptor-positive breast cancer uses proteins and hormones to support the growth or spread of the cancer. Hormone receptor-negative breast cancer does not use hormones to grow.

Hormone receptor-positive cancer cells depend on hormone receptors, such as estrogen receptors (see definition below) or progesterone receptors (a different type of receptor), to grow. Your doctor may also use the term estrogen receptor-positive.

Ask your doctor if you are not sure what your hormone receptor status is.

 
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Human epidermal growth factor receptor 2-negative

Human epidermal growth factor receptor 2 is a type of specialized receiver that can play a role in cancer growth. Cancer cells can be either human epidermal growth factor receptor 2-positive or human epidermal growth factor receptor 2-negative.

Human epidermal growth factor receptor 2-negative cancer cells may grow more slowly than cells with a high amount of human epidermal growth factor receptor 2.

Ask your doctor if you are not sure what your human epidermal growth factor receptor 2 status is.

 
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The estrogen receptor

If you have hormone receptor-positive metastatic breast cancer (see definition above), this means that the estrogen receptor—pictured near this text—may play a role in your cancer.

The estrogen receptor, which is the most common type of hormone receptor, can cause cancer to grow in several ways, explained below.

FASLODEX can connect with estrogen receptors much like how a baseball connects with a glove: by fitting into a specialized receiver. When FASLODEX fits into the estrogen receptor, it may be able to slow cancer growth by blocking* estrogen receptor activation.

*FASLODEX does not block 100% of estrogen receptors.

 

Why is the estrogen receptor an important factor in hormone receptor-positive metastatic breast cancer?

Hormone receptor-positive breast cancer relies on proteins and hormones inside your body to grow. The estrogen receptor is one of these proteins. It can cause cancer growth in several ways, such as by:

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Connecting with estrogen, which is a hormone that can send signals leading to the spread of cancer.

When FASLODEX connects with the estrogen receptor, the estrogen receptor’s ability to connect with estrogen is reduced.

signals

Sending signals that do not rely on estrogen inside cancer cells.

Breast cancer doesn’t always need estrogen to grow. Sometimes, the estrogen receptor can cause cancer growth without estrogen. FASLODEX works on the estrogen receptor rather than on estrogen.

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Participating in the cell cycle, which leads to tumor cell division.

Cancer grows when tumor cells divide and multiply. The estrogen receptor can start this process—but FASLODEX may be able to get in the way of the estrogen receptor.

Learn more about how FASLODEX works

FASLODEX acts in many ways. Below, you can learn more about how FASLODEX works on the estrogen receptor—and what that means for your treatment.

FASLODEX acts on the estrogen receptor

Select an option below to learn more about the impact FASLODEX can have on hormone receptor-positive metastatic breast cancer growth. FASLODEX is the only approved hormonal medicine that has been shown to interact with the estrogen receptor in these ways.

Connect with the estrogen receptor

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When FASLODEX connects with estrogen receptors, those estrogen receptors can react by:

  • Losing stability, meaning that they will not work as well
  • Changing shape, affecting their ability to bind to estrogen

As demonstrated in laboratory studies.

 
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FASLODEX impacts the way estrogen receptors work by connecting to them.

 

Block estrogen receptor activation

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Estrogen receptors that are connected to FASLODEX have a reduced ability to activate or communicate with estrogen. Inactive estrogen receptors cannot participate in cancer growth.

 
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FASLODEX interferes with estrogen receptors’ ability to activate.

 

FASLODEX does not block 100% of estrogen receptors.

Break down the estrogen receptor

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Estrogen receptors that are connected to FASLODEX break down quickly, resulting in fewer estrogen receptors in cancer cells.

 
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Broken down estrogen receptors cannot participate in the process of cancer growth.

 

Decrease the number of estrogen receptors

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When FASLODEX decreases the number of available estrogen receptors in breast cancer cells, estrogen receptors’ ability to cause cancer cells to divide and multiply is impacted.

FASLODEX is associated with a decrease in Ki67, a marker of cancer growth.

 
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Having fewer available estrogen receptors makes it more difficult for estrogen receptors to support cancer growth.

 

IMPORTANT SAFETY INFORMATION

    You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.

    Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:

  • Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
  • Have liver problems
  • Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
  • Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.

FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.

FASLODEX may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.

Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.

Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.

Approved Uses for FASLODEX

FASLODEX is a prescription medicine used to treat women with:

  • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
  • HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
  • HR-positive, HER2‐negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib, in women whose disease has progressed after endocrine therapy

When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.

When FASLODEX is used in combination with abemaciclib, please also see the abemaciclib Patient Information.

It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.

Please see FASLODEX Prescribing Information with Patient Information (Medication Guide).

 
 
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IMPORTANT SAFETY INFORMATION

    You should not receive FASLODEX if you have had an allergic reaction to fulvestrant or any of the ingredients in FASLODEX. Talk to your health care provider if you experience symptoms of an allergic reaction to FASLODEX, which may include itching or hives; swelling of your face, lips, tongue, or throat; and trouble breathing.

    Before receiving FASLODEX, tell your health care provider about all of your medical conditions, including if you:

  • Have a low level of platelets in your blood or bleed easily. Especially tell your health care provider if you take a blood thinner medicine (anticoagulant)
  • Have liver problems
  • Are pregnant or plan to become pregnant, because FASLODEX can harm your unborn baby. Women who are able to become pregnant should use effective birth control during treatment with FASLODEX and for 1 year after the final dose. Tell your health care provider right away if you become pregnant or think you are pregnant while on FASLODEX
  • Are breastfeeding or plan to breastfeed. It is not known if FASLODEX passes into breast milk. Do not breastfeed during treatment with FASLODEX and for 1 year after the final dose. Talk to your health care provider about the best way to feed your baby during this time

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FASLODEX may affect the way other medicines work, and other medicines may affect how FASLODEX works.

FASLODEX is administered by your health care provider as an injection into the muscle of each buttock. Your health care provider may change your dose of FASLODEX if needed.

FASLODEX may cause injection site–related nerve damage. Call your health care provider if you develop any of the following symptoms in your legs following a FASLODEX injection: numbness, tingling, or weakness.

Common side effects of FASLODEX include injection site pain; nausea; muscle, joint, and bone pain; headache; tiredness; hot flashes; vomiting; loss of appetite; weakness; cough; shortness of breath; constipation; increased liver enzymes; and diarrhea.

Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects with FASLODEX. For more information, ask your health care provider or pharmacist. You may report side effects to the FDA at 1-800-FDA-10881-800-FDA-1088.

Approved Uses for FASLODEX

FASLODEX is a prescription medicine used to treat women with:

  • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who have gone through menopause and have not been previously treated with endocrine therapy
  • HR-positive advanced breast cancer, who have gone through menopause and whose disease has progressed after endocrine therapy
  • HR-positive, HER2‐negative advanced breast cancer or breast cancer that has spread to other parts of the body (metastatic), in combination with palbociclib or abemaciclib, in women whose disease has progressed after endocrine therapy

When FASLODEX is used in combination with palbociclib, please also see the palbociclib Patient Information.

When FASLODEX is used in combination with abemaciclib, please also see the abemaciclib Patient Information.

It is not known if FASLODEX is safe and effective in children or in people with severe liver problems.

Please see FASLODEX Prescribing Information with Patient Information (Medication Guide).